Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin (oral), Placebo.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome, Obesity & Overweight, HIV (Human Immunodeficiency Virus). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus
Overview
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
Detailed description
HIV remains a major global public health concern. In 2024, approximately 40.8 million people were living with HIV worldwide. Around 630,000 deaths occurred due to AIDS-related illnesses. The preferred first-line ART regimen includes: Tenofovir disoproxil fumarate (TDF)+Emtricitabine (FTC) or Lamivudine (3TC)+Dolutegravir (DTG).
The introduction of highly active antiretroviral therapy transformed HIV from a fatal disease into a manageable chronic condition, significantly reducing morbidity and mortality.
Integrase strand transfer inhibitors (INSTIs), particularly dolutegravir (DTG), have been associated with greater weight gain compared with non-INSTI antiretroviral regimens.
The observed weight gain is strongly linked to adverse metabolic outcomes, including increased incidence of metabolic syndrome, higher rates of insulin resistance, and dyslipidemia.
Individuals living with HIV receiving antiretroviral therapy (ART) have been shown to have approximately 1.5-fold higher odds of developing metabolic syndrome (MetS).
Over the long term, these alterations contribute to a significantly elevated risk of cardiovascular disease, including myocardial infarction and stroke.
Evidence from biopsy-based studies further demonstrates a substantial burden of (NAFLD), (NASH), and liver fibrosis among people living with HIV (PLWH).
On the other hand, Sodium-glucose co-transporter-2 (SGLT2) inhibitors have demonstrated:
Cardiovascular benefits: Reduction in major adverse cardiovascular events in patients with atherosclerotic disease, including those with hypertension, dyslipidemia, and obesity.
Metabolic control: Improved glycemia via renal glucose reabsorption inhibition, lowering hyperglycemia with minimal hypoglycemic risk.
Weight and metabolic effects: Reduced body weight, BMI, SBP, visceral adiposity, insulin resistance, improved oral glucose tolerance test (OGTT) values and fasting insulin, even in non-diabetic individuals.
Hepatic outcomes: Significant reduction in liver fat content in metabolic disorders, mediated by improved lipid metabolism, insulin sensitivity, and reduced hepatic inflammation, supporting metabolic dysfunction-associated steatotic liver disease (MASLD) management.
These combined effects make SGLT2 inhibitors a promising therapeutic option for addressing the multiple facets of metabolic syndrome.
Interventions
- Drug Empagliflozin (oral)
Empagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys. This prevents glucose reabsorption, causing excess sugar to be excreted in urine. It helps lower blood sugar levels and can also reduce body weight and blood pressure. - Drug Placebo
TDF/FTC+DLG
Primary outcome measures
- Weight change [Time frame: 6 months]
Secondary outcome measures (9)
- Change in Total Cholesterol [Time frame: 6 months]
- Change in Fasting Blood Glucose [Time frame: 6 months]
- Change in Glycated Hemoglobin (HbA1c) [Time frame: 6 months]
- Change in Serum Creatinine [Time frame: 6 months]
- Change in Systolic and Diastolic Blood Pressure [Time frame: 6 months]
- Change in Body Mass Index (BMI) [Time frame: Baseline and 6 months]
- Change in Waist Circumference [Time frame: Baseline, 3 and 6 months]
- Change in Absolute CD4+ T-cell Count [Time frame: baseline and 6 months]
- Change in Plasma HIV-1 RNA Viral Load [Time frame: baseline and 6 months]
Eligibility criteria
Inclusion criteria
- Age >18 years up to 65 years old.
- Body Mass Index (BMI) > 30 kg/m\^2.
- Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).
- Sustained virologic suppression, defined as HIV-1 RNA < 200 copies/mL for at least 6 months.
- Current CD4 count > 250 cells/mL.
- Ability and willingness to provide written informed consent.
Exclusion criteria
- Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level > 126 mg/dL or glycated hemoglobin (HbA1c) > 6.5% (or per ADA definition).
- Renal impairment (e.g., eGFR < 60 ml/min/1.73m\^2).
- Active viral hepatitis B or C.
- Hypersensitivity to empagliflozin or any of its excipients.
- Pregnancy or breastfeeding.
- Current use of other SGLT-2 inhibitors.
- Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).
- Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).
- Known thyroid disease, defined as TSH > 6.0 mIU/L or < 0.35 mIU/L
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo — Cairo
Identifiers
NCT: NCT07336797 · CL(3828)